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`Page 121
`
`MAUREEN DONOVAN, Ph.D.
`
`reach
`
`the lungs to achieve the treatment goal
`
`that the Patton device is capable of being
`
`utilized to do that.
`
`BY MS.
`
`ASCARRUNZ:
`
`(Reporter Clarification.)
`
`Q.
`
`Earlier in your discussion of
`
`a POSA being motivated to modify the device
`
`used in Voswinckel, you referred to the
`
`Voswinckel Exhibit 1047 reference.
`
`Do you recall that discussion?
`
`A.
`
`I
`
`think I need to be reminded
`
`what the Voswinckel 1047 reference is.
`
`Q.
`
`Sometimes we refer to it as
`
`Voswinckel II, but it's the European Heart
`
`Journal.
`
`A.
`
`Okay.
`
`Can I
`
`take a look at
`
`that reference?
`
`MR. MATHAS:
`
`1046?
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`A.
`
`abstract.
`
`Did I -- sorry, 1046.
`
`So it's European Heart Journal
`
`Q.
`
`Yes.
`
`
`
`A.
`Okay. Yes. All right.
`
`
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`Page 121 of 201
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`Page 122
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`MAUREEN DONOVAN , Ph . D .
`
`Q.
`
`So when I asked you about
`
`the
`
`motivation in Voswinckel
`
`to modify the device,
`
`you told -- you referred me to this other
`
`Voswinckel reference and said that it tells you
`
`that they are open to the opportunity of
`
`improvements or changes in a nebulizer to
`
`advantage some characteristics of those
`
`nebulizers for improved patient therapy.
`
`A.
`
`Q.
`
`Do you recall that testimony?
`
`Yes.
`
`What does this reference which
`
`I will start referring to as Voswinckel II just
`
`for clarity of the record, tell you about the
`
`willingness of the investigators to improve -—
`
`to make improvements or changes to the
`
`nebulizer?
`
`A.
`
`Well,
`
`the Voswinckel II
`
`abstract describes the use of an OptiNeb
`
`ultrasound nebulizer and a six-minute
`
`inhalation exposure, and the Voswinckel
`
`American Heart Association abstract describes
`
`using three single breaths from a pulsed
`
`OptiNeb ultrasonic nebulizer, and it was
`
`
`
`certainly very well known in the field for
`
`
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`Page 123
`
`MAUREEN DONOVAN , Ph . D .
`
`nebulizer therapy that reducing the amount of
`
`time to achieve the dose needed for a patient
`
`was an important aspect of nebulizer therapy
`
`and patient adherence to nebulizer therapy.
`
`So moving from a six-minute
`
`nebulization to a three inhalation therapy
`
`whether that was accomplished exactly by a
`
`change in nebulizer or accomplished by other
`
`activities in addition was certainly something
`
`that Voswinckel demonstrates that groups were
`
`aware of and were in relatively similar
`
`timeframes evaluating the opportunity to use a
`
`device that provided a better user experience.
`
`Q.
`
`Okay. Now, you are aware that
`
`the single ground that the Board instituted for
`
`decision in this trial was the question --
`
`speaking just to the '240 patent, was limited
`
`to the question of obviousness over Voswinckel
`
`in view of Patton and Ghofrani, correct?
`
`A.
`
`Q.
`
`In the '240 patent, yes.
`
`But it's your opinion that in
`
`part a motivation to combine those references
`
`is evidenced by Voswinckel II, correct?
`
`
`
`I don't need Voswinckel
`No,
`A.
`
`
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`Page 124
`
`MAUREEN DONOVAN, Ph.D.
`
`II, but you were asking directly about specific
`
`statements in Voswinckel I, and because it's an
`
`abstract, it's a very short description of work
`
`conducted and has often times very little
`
`description about what other information the
`
`authors are thinking, and so I
`
`look to other
`
`evidence even from the same group to
`
`demonstrate that, yes,
`
`those other -- those
`
`investigators were thinking about other things
`
`to improve this therapy beyond just the mere
`
`words that are included in the written
`
`description in the abstract.
`
`Voswinckel II to come to the —— to come to the
`
`And so I don't need to rely on
`
`opinions that I did in the matter of the '50?
`
`or
`
`'240 patents. Merely use that as an obvious
`
`example of even whether it's -- whether
`
`something is actually stated clearly in an
`
`abstract.
`
`It was clear that even that same
`
`research group understood that that was a
`
`consideration and a motivation.
`
`Q.
`
`Okay.
`
`So because Voswinckel I
`
`is an abstract and it's a very short
`
`
`
`description of work conducted and has often
`
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`Page 125
`
`MAUREEN DONOVAN , Ph . D .
`
`times very little description about what other
`
`information the authors are thinking, you
`
`looked to Voswinckel II to supplement that
`
`understanding, correct?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`No,
`
`that‘s not correct.
`
`I
`
`didn't need to look to Voswinckel II. We
`
`started discussing Voswinckel II because I was
`
`answering questions you were asking about
`
`specific statements included in the Voswinckel
`
`I abstract that would have described the
`
`author‘s thoughts, desires,
`
`I don't remember
`
`the wording about the nebulizer, and I provided
`
`you with actual evidence of what would be clear
`
`to a POSA that there -- that those
`
`investigators must have been thinking about
`
`issues regarding modifying the nebulizers being
`
`used because they demonstrated that they even
`
`did that in order to modify the dosing regimen
`
`that they used that was different between those
`
`two, but I don't need to rely on Voswinckel II
`
`for that.
`
`I was using that as an example to
`
`
`
`answer your questions.
`
`
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`Page 126
`
`MAUREEN DONOVAN, Ph.D.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Do you need to refer to
`
`Voswinckel II to understand the motivation of
`
`the Voswinckel I authors to modify the device
`
`disclosed therein?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`No. Again, a POSA understood
`
`that certainly at the time of the priority date
`
`of the ‘240 and the '50? patents it was well
`
`known that in evaluating human factors and
`
`improving the human interface with devices was
`
`an important
`
`thing to do in order to improve
`
`user -- improve the use of the device,
`
`improve
`
`the adherence to the design dosing strategies
`
`and so forth.
`
`It was -- POSA's were well
`
`aware of those issues and were motivated to try
`
`to find ways to improve devices to address
`
`human factors issues and improve patient
`
`interactions with devices.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Okay. Where in Voswinckel I
`
`
`
`is it said that three breaths are delivered in
`
`
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`Page 127
`
`MAUREEN DONOVAN , Ph . D .
`
`less than six minutes?
`
`A.
`
`It doesn't -- let's see.
`
`Voswinckel
`
`I doesn't specifically indicate the
`
`timeframe over which the three breaths were
`
`taken, but a POSA reading this and, again, if
`
`it was -- if the occurrence or the
`
`description -- start over.
`
`If the methodology used by the
`
`investigators was going to differ significantly
`
`from what a reader of this abstract would be
`
`expected to understand,
`
`the authors typically
`
`make additional -- put in additional
`
`information into the abstract.
`
`So those
`
`methods are clear.
`
`So not having additional
`
`information indicates that a POSA is free to
`
`believe that this medication was dosed in the
`
`same way You would dose other medications with
`
`the OptiNeb ultrasound nebulizer which means
`
`three single breaths receiving the dose over a
`
`relatively short interval of time, certainly
`
`far less than six minutes.
`
`Q.
`
`Okay. We were talking about
`
`
`
`paragraph 125, and the last sentence there you
`
`
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`Page 128
`
`MAUREEN DONOVAN , Ph . D .
`
`indicate:
`
`"A POSA would have a reasonable
`
`expectation of success with such a
`
`combination," which refers to the combination
`
`of Voswinckel and Patton, "because it simply
`
`seeks to improve upon the successful
`
`treatment
`
`already achieved."
`
`A.
`
`Q.
`
`Do you see that?
`
`I see that.
`
`Why would a POSA seek to
`
`improve a treatment that is already
`
`successful?
`
`A.
`
`Because while the treatment
`
`was therapeutically successful,
`
`the future of
`
`the treatment was having patients be able to
`
`use that treatment in -- and, you know, not
`
`have it be a lifestyle interference.
`
`So in
`
`addition to being able to demonstrate that it
`
`was a successful treatment in the acute study
`
`or even with the two patients who were using it
`
`for compassionate use,
`
`there's a -- there‘s a
`
`motivation to make improvements so that when
`
`that is sent out into patients using it in
`
`their homes and other situations,
`
`that again
`
`
`
`it's as easy as possible for them to adhere to
`
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`Page 129
`
`MAUREEN DONOVAN , Ph . D .
`
`the therapeutic regimen. And for the
`
`alterations to -- and the need to take Patton's
`
`teaching about an optical and sound based
`
`indicator and combine that, a POSA wouldn‘t --
`
`would have every expectation that that could be
`
`achieved.
`
`Q.
`
`You reviewed the file
`
`histories of both patents at issue, correct?
`
`A.
`
`Q.
`
`I did quite a while ago, yes.
`
`Do you recall reviewing the
`
`declarations of -- of a Dr. Rubin?
`
`A.
`
`I -- only vaguely.
`
`I know I
`
`speak to it in my report, but I would need to
`
`see that declaration again to remind myself
`
`what it said.
`
`Q.
`
`Do you recall reviewing the
`
`declaration of a Dr. Zamanian?
`
`A.
`
`Again,
`
`I
`
`think I recall.
`
`I
`
`mean,
`
`I know there was something about material
`
`provided by Dr. Zamanian, but I don't recall in
`
`what aspects.
`
`Q.
`
`Okay.
`
`Do you recall reviewing
`
`a declaration of a Dr. Elder?
`
`
`
`It's been a
`I'm not sure.
`A.
`
`
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`Page 130
`
`MAUREEN DONOVAN, Ph.D.
`
`very long time since I have looked at those
`
`file histories.
`
`Q.
`
`And you recalled that you may
`
`have discussed Dr. Rubin's declaration
`
`somewhere in your declaration, correct?
`
`A.
`
`I
`
`thought that I did. Yes,
`
`in
`
`paragraph 210 in the '240 declaration,
`
`I
`
`mention what I understood Dr. Rubin's
`
`declaration to communicate.
`
`Q.
`
`And what did you understand
`
`that to be?
`
`A.
`
`Well, Dr. Rubin was -- I
`
`think
`
`it's -- I can only summarize essentially what‘s
`
`in this paragraph.
`
`I think -— I am sure
`
`there's more in the declaration I should speak
`
`to.
`
`So I would like to review it briefly.
`
`Q.
`
`In the course of forming your
`
`opinions in this case, did you at any point
`
`form an opinion that Dr. Rubin's declaration
`
`and the file histories was not credible?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`Again, it's been a long time
`
`
`
`since I have reviewed the file history or the
`
`
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`Page 131
`
`MAUREEN DONOVAN , Ph . D .
`
`declarations.
`
`So I would need to refresh my
`
`memory about what that specific declaration
`
`said and whether there were other things I
`
`evaluated as I read that.
`
`BY MS . ASCARRUNZ:
`
`Q.
`
`Well, certainly nowhere in
`
`your declaration did you articulate an opinion
`
`that Dr. Rubin is not credible, correct?
`
`A.
`
`No,
`
`I did not communicate that
`
`in my declaration.
`
`Q.
`
`Did you communicate anywhere
`
`in your declaration that Dr. Zamanian is not
`
`credible?
`
`A.
`
`I don't know that I recall
`
`that there‘s a description of Dr. Zamanian's
`
`declarations in this report.
`
`Q.
`
`Okay. Are you aware that both
`
`Drs. Rubin and Dr. Zamanian are medical doctors
`
`with an expertise in treating patients with
`
`pulmonary hypertension?
`
`A.
`
`I
`
`think people have told me
`
`that that‘s their background.
`
`Q.
`
`You don't claim to know more
`
`
`
`than Dr. Rubin or Dr. Zamanian regarding the
`
`
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`Page 132
`
`MAUREEN DONOVAN, Ph.D.
`
`medical
`
`treatment of pulmonary hypertension,
`
`correct?
`
`A.
`
`Q.
`
`That's correct.
`
`And you don't claim to know
`
`more than Dr. Rubin or Dr. Zamanian regarding
`
`patient responses to the treatment of pulmonary
`
`hypertension with inhaled treprostinil,
`
`correct?
`
`A.
`
`Clinically observable patient
`
`responses?
`
`Q.
`
`A.
`
`Yes.
`
`No,
`
`I don't know more than
`
`those two physicians, no.
`
`Q.
`
`You are aware that there's a
`
`consideration in this case as one of the
`
`objective indicia as to whether or not TYVASO
`
`is commercially successful, correct?
`
`A.
`
`I understand that that's
`
`certainly part of the case, yes.
`
`Q.
`
`And you are aware that TYVASO
`
`has been sold on the market since its approval
`
`by the FDA, correct?
`
`A.
`
`That's -- I mean, that's my
`
`
`
`I haven't tracked any time that it
`assumption.
`
`
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`Page 133
`
`MAUREEN DONOVAN, Ph.D.
`
`had been in shortage or not available.
`
`Q.
`
`Okay. And you agree that the
`
`attributes of TYVASO that drive its sales
`
`include the frequency of its administration,
`
`its shorter duration of treatment time as
`
`compared to Ventavis, and its efficacy,
`
`correct?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`Can you restate that question?
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`A.
`
`Q.
`
`Yes.
`
`Or at least reread it.
`
`Do you agree that the
`
`attributes of TYVASO that drive its sales
`
`include the frequency of its administration,
`
`its shorter duration treatment time as compared
`
`to Ventavis, and its efficacy?
`
`MR. MATHAS:
`
`Same objection.
`
`BY THE WITNESS:
`
`A.
`
`Well,
`
`I understand that there
`
`are differences between TYVASO and other
`
`pulmonary inhalation products for pulmonary
`
`
`
`hypertension that allow TYVASO to have
`
`
`800-642-1099
`
`A Veritext Company
`
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`Page1330f201
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`Page 134
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`MAUREEN DONOVAN , Ph . D .
`
`administration characteristics that might be
`
`preferred by patient users.
`
`It is well known
`
`that treprostinil was particularly pulmonary
`
`selective.
`
`The half life of TYVASO provides
`
`or -- provides the opportunity to have a longer
`
`duration between administrations.
`
`The ability
`
`of -- to formulate TYVASO or treprostinil at a
`
`concentration that allows a reduced number of
`
`inhalations allow the product known as TYVASO
`
`to have the characteristics it has.
`
`Q.
`
`Let me ask you about paragraph
`
`213 of your
`
`'240 declaration.
`
`The first
`
`sentence of paragraph 213 you state:
`
`"I
`
`understand that the examiner rejected each and
`
`every one of these secondary consideration
`
`arguments, and I agree especially in light of
`
`the teachings of Voswinckel and Ghofrani."
`
`A.
`
`Q.
`
`Do you see that?
`
`I see that.
`
`And you don't cite any
`
`particular portion of the file history for that
`
`statement, correct?
`
`A.
`
`I didn't cite it in this
`
`
`
`particular paragraph, no.
`
`
`800-642-1099
`
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`Page1340f201
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`Page 135
`
`MAUREEN DONOVAN , Ph . D .
`
`Q.
`
`Did you have in mind when you
`
`wrote this sentence where the examiner rejected
`
`each and every one of the patent owner's
`
`secondary consideration arguments?
`
`A.
`
`Again,
`
`I don't recall a
`
`specific section because, again, it's been a
`
`really long time since I
`
`looked at the file
`
`histories.
`
`I don't remember the sequence of
`
`rejections and responses and final
`
`determinations.
`
`Q.
`
`Okay. But do you stand by the
`
`statement that the examiner rejected each and
`
`every one of the patent owner's secondary
`
`consideration arguments?
`
`A.
`
`In the absence of being able
`
`to review the file history, yes.
`
`I believe
`
`that my understanding of the record as I read
`
`it and wrote my report is that the examiner
`
`rejected each and every one of the secondary
`
`considerations arguments.
`
`Q.
`
`And do you know with respect
`
`to what claims the examiner rejected such
`
`arguments?
`
`
`
`I have no recollection on the
`A.
`
`
`800-642-1099
`
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`Page 136
`
`MAUREEN DONOVAN, Ph.D.
`
`details of the -- again,
`
`the rejections and the
`
`responses and the rejections and the responses
`
`that are part of the file histories.
`
`Q.
`
`You are obviously aware that
`
`some claims issued in both of the patents that
`
`are at issue in this case in the IPR
`
`proceedings, correct?
`
`A.
`
`Well,
`
`that there are claims
`
`issued for the '50? patent and the '240 patent.
`
`So, yes,
`
`some claims issued.
`
`Q.
`
`And that necessarily means the
`
`examiner found those claims to be non-obvious,
`
`correct?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`Again,
`
`those claims issued,
`
`but exactly what the patent examiner evaluated,
`
`how they made their determination to issue
`
`those is beyond my ability to comment on.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`And that includes the
`
`examiner's opinions with respect to objective
`
`indicia, correct?
`
`
`
`Same objection.
`MR. MATHAS:
`
`
`800-642-1099
`
`A Veritext Company
`
`www.veritext.com
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`Page1360f201
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`Page 137
`
`MAUREEN DONOVAN , Ph . D .
`
`BY THE WITNESS:
`
`A.
`
`The claims issued. That's
`
`what I understand.
`
`BY MS . ASCARRUNZ:
`
`Q.
`
`I want to go back to Our
`
`discussion about the word pulsed, and before we
`
`do that, let's maybe set the context and have
`
`both of the two patents at issue in front of
`
`you.
`
`And looking to the '240
`
`patent -- the ‘240 patent, do you agree with me
`
`that a requirement of the claims includes the
`
`use of a quote "pulsed ultrasonic nebulizer"?
`
`A.
`
`Yes,
`
`in both claim 1 -- claim
`
`1 in both the '240 and the '507 include the
`
`phrase pulsed ultrasonic nebulizer, and a POSA
`
`would understand that term to mean an
`
`ultrasonic nebulizer that's capable of
`
`delivering the aerosols in a pulsed manner.
`
`Q.
`
`So your understanding of the
`
`word pulsed in the context of the claims of
`
`both patents is that it is -- that the phrase
`
`pulsed ultrasonic nebulizer means an ultrasonic
`
`
`
`nebulizer that is capable of delivering the
`
`
`800-642-1099
`
`A Veritext Company
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`Page1370f201
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`Page 138
`
`MAUREEN DONOVAN , Ph . D .
`
`aerosols in a pulsed manner, correct?
`
`A.
`
`Well, as I -- you know, as we
`
`read the remaining description about the pulsed
`
`ultrasonic nebulizer in claim 1, and I am
`
`looking at the '240 patent, it's requiring it
`
`to be able to deliver a fixed amount of
`
`treprostinil or pharmaceutically acceptable
`
`salt.
`
`30 that fixed amount indicates that it's
`
`being delivered as a pulse where there's a
`
`pause in time where there's not delivery
`
`happening.
`
`Q.
`
`In your reading of the claim,
`
`does it indicate how long that period of time
`
`is when there is a pause in time when there is
`
`not delivery happening?
`
`A.
`
`No,
`
`I don't read anything into
`
`the claim regarding the amount of -- the length
`
`of the time interval.
`
`Q.
`
`And there's nothing else in
`
`the claim that describes to you the length of
`
`the time interval?
`
`A.
`
`Well, later in the claim it
`
`describes the number of breaths that might be
`
`
`
`used to administer a particular mass of the
`
`
`800-642-1099
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`Page1380f201
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`
`
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`
`Page 139
`
`MAUREEN DONOVAN, Ph.D.
`
`drug treprostinil, and depending on what
`
`sequence of breaths somebody wanted to take,
`
`that indicates a possible amount of time that
`
`the total administration might take, but
`
`there‘s nothing within the claim that describes
`
`the specific length of time of the pulse.
`
`Q.
`
`Okay.
`
`Focusing again on the
`
`use of the word pulse in the claims and not
`
`just speaking in the abstract general English
`
`terminology, but focusing on the use of the
`
`word pulsed in the claims,
`
`is it your opinion
`
`that an ultrasonic nebulizer with a constant
`
`output that has a switch you can use to turn
`
`the device on and off can be a pulsed
`
`ultrasonic nebulizer within the meaning of the
`
`claims?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`I believe that an ultrasonic
`
`nebulizer that‘s capable of administering a
`
`fixed amount of the drug and then not -- not
`
`continue to aerosolized cOuld be viewed as a
`
`pulsed ultrasonic nebulizer.
`
`
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`A Veritext Company
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`www.veritext.com
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`David Feldrnan Worldwide
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`Page 140
`
`MAUREEN DONOVAN, Ph.D.
`
`BY MS.
`
`ASCARRUNZ:
`
`Q.
`
`Is it your opinion that an
`
`ultrasonic nebulizer with a constant output
`
`that has a switch you can use to turn the
`
`device on and off can be a pulsed ultrasonic
`
`nebulizer within the meaning of the claims?
`
`MR. MATHAS:
`
`Same objection.
`
`BY THE WITNESS:
`
`A.
`
`That same -- if the turning
`
`the switch off can discontinue the aerosol
`
`production and then switching the —- switching
`
`the nebulizer back on in whatever timeframe it
`
`is that is desired or required that delivers
`
`two pulses or if you switch it off again, it
`
`will deliver —— and switch it back on again, it
`
`will deliver three pulses of the medication.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`And in that instance then that
`
`would fall within the meaning of pulsed
`
`ultrasonic nebulizer in the claims?
`
`A.
`
`Well, because it's
`
`aerosolizing a fixed amount of treprostinil,
`
`yes.
`
`
`
`Q.
`Is it your opinion that an
`
`
`800-642-1099
`
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`Page 141
`
`MAUREEN DONOVAN , Ph . D .
`
`ultrasonic nebulizer with a timed uninterrupted
`
`stream of aerosol that lasts for ten seconds is
`
`a pulsed ultrasonic nebulizer?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`As long as the amount of
`
`aerosol is reproducible during the time that
`
`the aerosol is being produced and that there's
`
`a period of time where the aerosol is not being
`
`produced,
`
`that could be considered a pulsed
`
`delivery.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Can a pulse within the meaning
`
`of the claims last more than one breath?
`
`A.
`
`I don't see anything in the
`
`claims that indicates that there's a time
`
`duration requirement for the time between
`
`pulses.
`
`So there could be -- there could be
`
`other breaths between the breaths being used to
`
`inhale the aerosol.
`
`Q.
`
`Okay.
`
`If a device has
`
`intermittent periods of aerosol generation and
`
`no aerosol generation, would this be pulsed
`
`
`
`according to your understanding of the use of
`
`
`800-642-1099
`
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`
`Page 141 of 201
`
`
`
`
`
`Page 142
`
`MAUREEN DONOVAN, Ph.D.
`
`the terminology in the claims?
`
`A.
`
`Q.
`
`Can you repeat that, please?
`
`Sure.
`
`If a device has
`
`intermittent periods of aerosol generation and
`
`no aerosol generation, would this be pulsed
`
`within the meaning of the claims?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`I
`
`am still confused.
`
`One more
`
`time.
`
`BY MS.
`
`ASCARRUNZ:
`
`Q.
`
`Would it be considered pulsed
`
`within the meaning of the claims if a device
`
`were to have intermittent periods of aerosol
`
`generation and no aerosol generation?
`
`So it switches back and forth
`
`from aerosol generation, no aerosol generation,
`
`aerosol generation, no aerosol generation.
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`Yes,
`
`I believe that is within
`
`the definition of pulsed delivery from an
`
`ultrasonic nebulizer.
`
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`800-642-1099
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`A Veritext Company
`
`www.veritext.com
`
`David Feldrnan Worldwide
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`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01622
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`Page 143
`
`MAUREEN DONOVAN, Ph.D.
`
`BY MS.
`
`ASCARRUNZ:
`
`Q.
`
`Okay.
`
`If a device is turned
`
`on to generate aerosol,
`
`turned off to cease the
`
`aerosol generation, put down, and then turned
`
`on again after a period of time to generate
`
`aerosol, would this be pulsed according to the
`
`meaning of the claims?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`It -- I would certainly
`
`consider it could be. There —— there are a
`
`number of different ways that someone might
`
`configure an ultrasonic nebulizer and a
`
`solution of drug and the need of a particular
`
`patient or group of patients or whatever that
`
`conceivably might include a longer non-aerosol
`
`generation period.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Are you familiar with the term
`
`breath actuated in the art of inhalation
`
`therapy?
`
`A.
`
`Q.
`
`Yes,
`
`I am.
`
`If a device generates
`
`
`
`aerosol -- okay.
`In a breath-actuated device
`
`
`800-642-1099
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`Page1430f201
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`Page 144
`
`MAUREEN DONOVAN , Ph . D .
`
`where the device delivers aerosol
`
`to the
`
`patient due to the patient's breathing -- I'm
`
`sorry. Let me start all over.
`
`Can a breath-actuated device
`
`be a pulsed device within the meaning of the
`
`claims?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`It depends.
`
`If that breath
`
`actuated device is capable of or is designed to
`
`deliver that fixed amount regardless of the
`
`other factors in the patient inhalation, yes,
`
`it could be considered if it uses ultrasonic --
`
`a pulsed ultrasonic device.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`And when you say regardless of
`
`the other factors in the patient inhalation,
`
`did you have specific factors in mind?
`
`A.
`
`That most obvious is for how
`
`long does the Patient inhale and how is the
`
`aerosol being formed during that time.
`
`Q.
`
`Is the inspiratory flow of the
`
`patient also a factor?
`
`
`
`That's very dependent on
`A.
`
`
`800-642-1099
`
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`
`Page 144 of 201
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`Page 145
`
`MAUREEN DONOVAN, Ph.D.
`
`the --
`
`what's being emitted from the nebulizer
`
`whether the inspiratory flow add additional
`
`effects.
`
`Q.
`
`In your mind or in your
`
`opinion, does the requirement in the claims of
`
`a pulsed device require that the pulse equates
`
`to one breath?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`I
`
`think you could certainly
`
`be --
`
`there are -- would be circumstances
`
`where,
`
`yes, it could equate to one breath and
`
`each breath is a breath that is utilized to
`
`inhale the aerosol, and I
`
`think there could
`
`conceivably be breaths where they were part of
`
`the pause.
`
`BY MS.
`
`ASCARRUNZ:
`
`Q.
`
`Okay. And could there also
`
`conceivably be more than one breath per pulse?
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`MR. MATHAS: Object to the form.
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`BY THE
`
`WITNESS:
`
`A.
`
`Well, if the pulsed ultrasonic
`
`nebulizer was configured as a breath-actuated
`
`
`
`there could be the possibility, but,
`nebulizer,
`
`
`800-642-1099
`
`A Veritext Company
`
`www.veritext.com
`
`David Feldrnan Worldwide
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01622
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`Page145of201
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`Page 146
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`MAUREEN DONOVAN, Ph.D.
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`again,
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`there's some additional requirements
`
`that aren't really clearly specified in the
`
`claim so.
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`BY MS. ASCARRUNZ:
`
`Q.
`
`Okay.
`
`If I were to take a
`
`sort of standard asthma inhaler and take a puff
`
`and then wait a few seconds and then take
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`another puff,
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`is that pulse delivery?
`
`A.
`
`Under sort of the POSA's
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`understanding of pulse delivery versus multiple
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`dose delivery, yes.
`
`Q.
`
`Let me turn your attention to
`
`paragraphs 126 —- 126 of your
`
`'240
`
`declaration —— ‘50? declaration.
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`Thank you.
`
`Do you see where you discuss
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`that the primary purpose of using a pulsed
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`nebulizer is to avoid wasting the drug that
`
`gets aerosolized while the patient is exhaling?
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`A.
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`Q.
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`I see where it says that, yes.
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`Is this the only possible
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`purpose for using a pulsed nebulizer?
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`A.
`
`There are probably others, but
`
`this again is one of the key purposes for
`
`
`
`designing pulsed nebulizers or nebulizers that
`
`
`800-642-1099
`
`A Veritext Company
`
`www.veritext.com
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`David Feldman Worldwide
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01622
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`Page1460f201
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`Page 147
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`MAUREEN DONOVAN , Ph . D .
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`pause when the patient is not breathing and the
`
`aerosol that's being formed.
`
`Q.
`
`And how did you determine that
`
`this is the primary purpose?
`
`A.
`
`It's based on my experiences
`
`and teaching and understanding of the field of
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`nebulized drug delivery.
`
`Q.
`
`Let me ask you to look at
`
`paragraphs 37 and 38.
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`Do you consider the HaloLite‘s
`
`device to being a pulsed nebulizer?
`
`A.
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`It's a breath—actuated or
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`signaled-type nebulizer.
`
`I would have to look
`
`at the details I think again about the HaloLite
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`to find out whether there's anything else
`
`beyond my description in this paragraph to make
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`sure that it doesn't do something else that I
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`wouldn't consider it being a pulsed nebulizer,
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`but it has pause periods and periods that it
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`produces aerosol or at least directs aerosol
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`out the mouthpiece.
`
`Q.
`
`Unfortunately, we don't have
`
`this one printed so let me ask you to get out
`
`
`
`the two patents again.
`
`
`800-642-1099
`
`A Veritext Company
`
`www.veritext.com
`
`David Feldrnan Worldwide
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01622
`
`Page1470f201
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`Page 148
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`MAUREEN DONOVAN , Ph . D .
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`Both patents contain a
`
`dependent claim limitation, and I will direct
`
`you to claim 4 of both patents where the single
`
`event dose produces a peak plasma concentration
`
`of treprostinil about 10 to 15 minutes after
`
`the single event dose, right?
`
`A.
`
`Q.
`
`Yes,